A Study of Daratumumab

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Platelet Disorders

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

Daratumumab

Pomalidomide

Lenalidomide

Clinical Study ID

NCT05438043
CR109200
54767414MMY3030
2021-006494-33
2022-500138-27-00
  • All Genders

Study Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be actively receiving daratumumab (either as monotherapy or incombination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab studyfor participants with multiple myeloma or smoldering multiple myeloma which hasreached clinical cutoff for final analysis continue to benefit from study treatment,not have experienced disease progression or unmanageable toxicity while receivingdaratumumab, not have met the withdrawal criteria set forth in the parent study, andhave had the last dose of study treatment within the previous 3 months

  • Investigator's assessment that the benefit of continued study treatment willoutweigh the risks

  • A female participant of childbearing potential must have a negative pregnancy testat screening and must agree to further serum or urine pregnancy tests during thestudy

  • A male participant must agree not to donate sperm for the purpose of reproductionduring the study and for a minimum of 3 months after receiving the last dose ofstudy treatment

  • Must sign an informed consent form (ICF; or their legally acceptable representativemust sign) indicating that the participant understands the purpose of, andprocedures required for, the study and is willing to participate in the study

  • Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion

Exclusion Criteria:

  • Has taken any disallowed therapies or treatment for the disease under study betweenthe completion of the parent study and the planned first dose of study treatment

  • Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the participant (for example, compromise the well-being)or that could prevent, limit, or confound the protocol-specified assessments

  • Known allergies, hypersensitivity, or intolerance to study treatments or theirexcipients (refer to the daratumumab investigator brochure (IB) and local countryprescribing information for dexamethasone, carfilzomib, pomalidomide, andlenalidomide)

  • Vaccinated with an investigational vaccine (except for Coronavirus disease [COVID-19])or live attenuated or replicating viral vector vaccines within 4 weeksprior to enrollment

Study Design

Total Participants: 500
Treatment Group(s): 5
Primary Treatment: Daratumumab
Phase: 3
Study Start date:
December 15, 2022
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • ZNA Stuivenberg

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Beijing Chaoyang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100006
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

  • Peking University People s Hospital

    Beijing, 100044
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • West China Hospital Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital, Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • Fujian Medical University

    Fuzhou, 350001
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, 510515
    China

    Site Not Available

  • First Affiliated Hospital Medical School of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • Harbin medical university cancer hospital

    Harbin, 150000
    China

    Site Not Available

  • Zhongda Hospital,Southeast University

    Nanjing, 210000
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    ShangHai, 200127
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, 200003
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • First Affiliated Hospital SooChow University

    Suzhou, 215006
    China

    Active - Recruiting

  • First Affiliated Hospital, SooChow University

    Suzhou, 215006
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300320
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin, 300320
    China

    Site Not Available

  • Tianjin cancer hospital

    Tianjin, 300060
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Completed

  • Aarhus University Hospital

    Aarhus N, DK-8200
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Caen

    Caen, 14033
    France

    Completed

  • CHU Nantes

    Nantes Cedex 1, 44000
    France

    Site Not Available

  • Hopital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Haut Leveque

    Pessac, 33604
    France

    Completed

  • Hôpital Haut-Lévêque

    Pessac, 33604
    France

    Site Not Available

  • CHU Bretonneau

    Tours Cedex 9, 37044
    France

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113
    Germany

    Site Not Available

  • Asklepios Klinik Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

    Tübingen, 72076
    Germany

    Completed

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28
    Greece

    Site Not Available

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39
    Greece

    Completed

  • Sapienza University of Rome

    Roma, 00161
    Italy

    Completed

  • Universita Degli Studi di Roma Tor Vergata

    Roma, 00133
    Italy

    Completed

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang si, 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-800
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Hospital

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284
    Russian Federation

    Active - Recruiting

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126
    Russian Federation

    Active - Recruiting

  • Republican Hospital named by V.A.Baranova

    Petrozavodsk, 185019
    Russian Federation

    Active - Recruiting

  • Ryazan Regional Clinical Hospital

    Ryazan, 390003
    Russian Federation

    Active - Recruiting

  • City Hospital No.15

    Saint-Petersburg, 198205
    Russian Federation

    Active - Recruiting

  • Saratov State Medical University

    Saratov, 410012
    Russian Federation

    Active - Recruiting

  • Clinical Research Institute of Hematology and Transfusiology

    St-Petersburg, 191024
    Russian Federation

    Active - Recruiting

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904
    Russian Federation

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Inst. Cat. Doncologia-H Duran I Reynals

    Hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Inst. Cat. Doncologia-H Duran I Reynals

    Hospitalet de Llobregat, Barcelona, 08908
    Spain

    Site Not Available

  • Hosp. Univ. de Canarias

    La Laguna, 38320
    Spain

    Site Not Available

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050
    Spain

    Site Not Available

  • Clinica Univ. De Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Univ. 12 De Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hosp. Gral. Univ. J.M. Morales Meseguer

    Murcia, 30008
    Spain

    Completed

  • Clinica Univ. De Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Univ. Dr. Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

    Dnepropetrovsk, 49102
    Ukraine

    Site Not Available

  • Kharkov Regional Clinical Oncology Center, Dept. of Hematology

    Kharkov, 61070
    Ukraine

    Site Not Available

  • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

    Vinnitsa, 21018
    Ukraine

    Site Not Available

  • St James University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Surrey, SM2 5PT
    United Kingdom

    Site Not Available

  • University of Miami Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Barnes-jewish Hospital

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

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